BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2810244 · Received October 31, 2012

    Report

    Report Number
    3004209178-2012-09754
    Event Type
    Injury
    Date Received
    October 31, 2012
    Report Date
    October 2, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER, PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 37092, LOT# 240620003, IMPLANTED: 2010 (B)(6), PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE CAUSE OF THE EVENT WAS PATIENT'S DISSATISFACTION WITH COVERAGE. THERE WERE NO ABNORMAL IMPEDANCE MEASUREMENTS. THE LEAD AND IMPLANTABLE NEUROSTIMULATOR (INS) WERE EXPLANTED AND PATIENT OUTCOME WAS NOTED AS NO INJURY. IT WAS ALSO STATED THAT REPROGRAMMING WAS NEVER HELPFUL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS NEVER ABLE TO GET STIMULATION IN HER TARGET AREA, HER FEET AND LEGS. THE DEVICE WAS REPROGRAMMED THREE OR FOUR TIMES WITHOUT SUCCESS. THE LEAD WAS REVISED TO MOVE IT LOWER. THE DEVICE WAS REPROGRAMMED AGAIN, FOLLOWING REVISION, BUT IT WAS 'TOO HIGH.' THE DEVICE WAS EXPLANTED SIX WEEKS PRIOR TO THE DATE OF THE REPORT. FURTHER INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention